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Research on the Development, Implementation Effect and Neural Mechanism of a Physical Intervention Program for College Students With ADHD Based on the Characteristics of Balance Dysfunction

Research on the Development, Implementation Effect and Neural Mechanism of a Physical Intervention Program for College Students With ADHD Based on the Characteristics of Balance Dysfunction

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07499427
Enrollment
130
Registered
2026-03-30
Start date
2025-10-07
Completion date
2026-02-15
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD, ADHD - Attention Deficit Disorder With Hyperactivity, ADHD - Combined Type, ADHD - Inattentive Type, ADHD Specifically With Executive Function Impairment

Keywords

ADHD

Brief summary

Background: Attention deficit/hyperactivity disorder is a common neurodevelopmental disorder. Its core symptoms and related executive function, emotional and motor coordination problems often persist into adulthood, significantly affecting the academic performance and quality of life of college students. Current drug interventions have limitations, while exercise interventions, especially training focused on balance ability, show potential in improving cognitive functions, but systematic research on this aspect for the college student population is still insufficient. Research Objectives: This study aims to explore the effects of different exercise intervention models on college students with attention deficit hyperactivity disorder. The main objectives include: The system assessment focuses on the characteristics of college students with attention deficit hyperactivity disorder in terms of core symptoms, executive functions, emotional issues, and balance abilities. Compare the effects of eight-week aerobic training, conventional balance training, and "cognitive-balance dual-task" training on improving the symptoms of attention deficit hyperactivity disorder and cognitive function. By utilizing functional near-infrared spectroscopy technology, we aim to explore the potential brain mechanisms (such as changes in activation of the prefrontal cortex) through which exercise intervention can improve attention deficit hyperactivity disorder. Participants: This study will recruit college students who meet the diagnostic criteria for attention deficit hyperactivity disorder as the experimental group, and at the same time recruit healthy college students of the same age and gender as the control group. Research Design: This study consists of three parts: Study 1 (Cross-sectional Comparison): To compare the baseline differences in symptoms, cognition, emotions, and balance ability between college students with attention deficit hyperactivity disorder and healthy college students. Study Two (Randomized Controlled Trial): College students with attention deficit hyperactivity disorder were randomly assigned to three 8-week (3 times per week) intervention groups: the aerobic treadmill training group, the conventional balance training group, and the cognitive-balance dual-task training group. All participants underwent comprehensive assessments before the intervention, 4 weeks into the intervention, and 8 weeks into the intervention. Study 3 (Exploration of Neural Mechanisms): Before and after the intervention, the functional near-infrared spectroscopy technique was used to detect the activation of the prefrontal cortex in college students with attention deficit hyperactivity disorder when they were performing cognitive tasks. Measurement indicators: The study will use standardized scales to assess the core symptoms of attention deficit hyperactivity disorder, anxiety, depression, self-esteem, and quality of life; use neuropsychological tasks to evaluate "cold" and "hot" executive functions; and use high-precision balance testing systems (such as the Biodex Balance Analyzer, Y Balance Test) to assess postural control and dynamic balance abilities. Expected significance: This study is expected to provide a scientific and effective new non-pharmacological intervention plan for adult attention deficit hyperactivity disorder, and clarify the "brain-behavior" mechanism of the synergistic enhancement of "cognitive-motor" training, providing a theoretical basis for future personalized and mechanism-driven clinical rehabilitation strategies.

Interventions

Participants undergo structured aerobic training on a treadmill for 30 minutes per session, 3 times per week over 8 weeks. Each session includes a 5-minute warm-up (slow walking/jogging), 20 minutes of main exercise, and a 5-minute cool-down. Intensity is maintained at moderate level (60-75% of heart rate maximum, HRmax) monitored by heart rate monitor, and Borg Rating of Perceived Exertion (RPE) scale 12-14 ("somewhat hard" to "hard"). The intervention aims to improve cardiorespiratory fitness and general health.

Participants receive progressive balance training for 30 minutes per session, 3 times per week for 8 weeks. Training follows a 3-phase progression: Phase 1 (weeks 1-2): static stance and weight shifting on stable surfaces; Phase 2 (weeks 3-5): dynamic tasks on unstable surfaces (e.g., balance pads, wobble boards) with vestibular challenges; Phase 3 (weeks 6-8): functional multi-task activities (e.g., single-leg stance with trunk rotation, holding objects). Difficulty is manipulated by altering base of support, visual input (eyes open/closed), and task complexity. All sessions are supervised by trained staff. The goal is to enhance static and dynamic balance and proprioceptive function.

BEHAVIORALCognitive-Balance Dual-Task Training

Participants undergo the same progressive balance training protocol as the Balance Training Group, but with simultaneous cognitive tasks superimposed throughout each session. Cognitive tasks include: serial subtraction, N-back tasks, alternating arithmetic operations, word generation/categorization, and Stroop tasks. These tasks engage working memory, cognitive flexibility, and attention. Training follows a progressive difficulty principle: initial weeks involve simple cognitive tasks during static balance; later weeks incorporate complex cognitive tasks during dynamic balance challenges. The dual-task interference is systematically increased to optimize cognitive resource allocation and postural control strategies. Sessions are 30 minutes, 3 times per week for 8 weeks, supervised by trained staff.

Sponsors

Wuhan Sports University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* The age range is from 18 to 30 years old, meeting the clinical diagnostic criteria for adult ADHD (DSM-5); * Diagnosed by a psychiatrist or clinical psychologist using standardized assessment tools (Adult ADHD Self-Rating Scale ASRS-5, Conners Adult ADHD-DIVA-5 Diagnostic Interview), and meeting the clinical diagnostic criteria for adult ADHD (DSM-5); * Not taking stimulant drugs to ensure that the symptom assessment is not influenced by the drugs;

Exclusion criteria

* Neurological disorders: such as brain injury, epilepsy, multiple sclerosis, etc., which may affect motor functions; * Orthopedic or musculoskeletal disorders: such as severe arthritis, muscle disorders, vestibular dysfunction, etc.; * Comorbid mental disorders: such as schizophrenia, bipolar disorder, severe depression or anxiety disorder; * Other interfering factors: such as severe visual or hearing impairments, history of alcohol or drug dependence, etc.

Design outcomes

Primary

MeasureTime frameDescription
ADHD Core Symptom SeverityBaseline, Week 4 (mid-intervention), Week 8 (post-intervention)Change in ADHD core symptoms assessed by the Adult ADHD Self-Report Scale (ASRS). The ASRS is an 18-item self-report questionnaire measuring inattention and hyperactivity-impulsivity symptoms over the past week. Total scores range from 0 to 72, with higher scores indicating greater symptom severity.Score on a scale (0-72)
Working Memory - N-back Task AccuracyBaseline, Week 4 (mid-intervention), Week 8 (post-intervention)Change in working memory performance measured by accuracy (%) on the N-back task. Participants respond when the current stimulus matches the one presented N trials earlier. Higher accuracy indicates better working memory.Unit of Measure:Percentage (%)
Prefrontal Cortex ActivationBaseline (pre-intervention), Week 8 (post-intervention)Change in prefrontal cortex hemodynamic response measured by functional near-infrared spectroscopy (fNIRS) during cognitive tasks (N-back and emotional Stroop). Primary outcomes include oxygenated hemoglobin (HbO) concentration changes in the dorsolateral prefrontal cortex (DLPFC) and orbitofrontal cortex (OFC).
Cognitive Flexibility - Wisconsin Card Sorting Test Perseverative ErrorsBaseline, Week 4, Week 8Change in cognitive flexibility measured by the number of perseverative errors on the Wisconsin Card Sorting Test (WCST). Perseverative errors occur when participants persist with an incorrect sorting rule despite negative feedback. Fewer perseverative errors indicate better cognitive flexibility.Unit of Measure: Number of errors
Cognitive Flexibility - Wisconsin Card Sorting Test Categories CompletedBaseline, Week 4, Week 8Change in cognitive flexibility measured by the number of categories completed on the Wisconsin Card Sorting Test (WCST). A maximum of 6 categories can be completed. More categories completed indicate better cognitive flexibility.Unit of Measure: Number of categories
Inhibitory Control - Stroop Task Interference EffectBaseline, Week 4, Week 8Change in inhibitory control measured by the Stroop interference effect (mean reaction time for incongruent trials minus congruent trials) on the Stroop color-word task. Smaller interference effects indicate better inhibitory control.Unit of Measure: Milliseconds (ms)
Inhibitory Control - Stroop Task AccuracyBaseline, Week 4, Week 8Change in inhibitory control measured by accuracy (%) across all trial types on the Stroop color-word task. Higher accuracy indicates better performance.Unit of Measure:Percentage (%)
Affective Decision-Making - Iowa Gambling Task Net ScoreBaseline, Week 4, Week 8Change in affective decision-making measured by the net score (total advantageous selections minus total disadvantageous selections) on the modified Iowa Gambling Task. Higher net scores indicate better risk-adjusted decision-making.Unit of Measure:Net score
Affective Decision-Making - Iowa Gambling Task Reaction TimeBaseline, Week 4, Week 8Change in affective decision-making measured by mean reaction time (milliseconds) across all trials on the modified Iowa Gambling Task. Shorter reaction times indicate faster decision-making.Unit of Measure: Milliseconds (ms)
Emotional Interference Control - Emotional Stroop Task Interference EffectBaseline, Week 4, Week 8Change in emotional interference control measured by the emotional Stroop interference effect (mean reaction time for negative/emotional words minus neutral words). Larger interference effects indicate greater emotional distractibility.Unit of Measure:Milliseconds (ms)
Emotional Interference Control - Emotional Stroop Task AccuracyBaseline, Week 4, Week 8Change in emotional interference control measured by accuracy (%) across all trial types on the emotional Stroop task. Higher accuracy indicates better performance.Unit of Measure:Percentage (%)
Functional Balance - Berg Balance Scale Total ScoreBaseline, Week 4, Week 8Change in functional balance measured by the Berg Balance Scale (BBS) total score. The BBS assesses ability to maintain balance during 14 daily activities (e.g., sitting, standing, reaching, turning). Total scores range from 0 to 56. Higher scores indicate better balance performance.
Gait Performance - Functional Gait Assessment Total ScoreBaseline, Week 4, Week 8Change in complex gait performance measured by the Functional Gait Assessment (FGA) total score. The FGA evaluates gait during 10 tasks (e.g., walking with head turns, stepping over obstacles, walking backward). Total scores range from 0 to 30. Higher scores indicate better gait performance.
Dynamic Balance - Y-Balance Test Right Anterior Reach DistanceBaseline, Week 4, Week 8Change in dynamic balance measured by the normalized reach distance (%) of the right leg in the anterior direction on the Y-Balance Test. Reach distance is normalized to leg length. Longer reach distances indicate better dynamic balance.
Dynamic Balance - Y-Balance Test Right Posteromedial Reach DistanceBaseline, Week 4, Week 8Change in dynamic balance measured by the normalized reach distance (%) of the right leg in the posteromedial direction on the Y-Balance Test. Reach distance is normalized to leg length. Longer reach distances indicate better dynamic balance.
Dynamic Balance - Y-Balance Test Right Posterolateral Reach DistanceBaseline, Week 4, Week 8Change in dynamic balance measured by the normalized reach distance (%) of the right leg in the posterolateral direction on the Y-Balance Test. Reach distance is normalized to leg length. Longer reach distances indicate better dynamic balance.
Dynamic Balance - Y-Balance Test Left Anterior Reach DistanceBaseline, Week 4, Week 8Change in dynamic balance measured by the normalized reach distance (%) of the left leg in the anterior direction on the Y-Balance Test. Reach distance is normalized to leg length. Longer reach distances indicate better dynamic balance.
Dynamic Balance - Y-Balance Test Left Posteromedial Reach DistanceBaseline, Week 4, Week 8Change in dynamic balance measured by the normalized reach distance (%) of the left leg in the posteromedial direction on the Y-Balance Test. Reach distance is normalized to leg length. Longer reach distances indicate better dynamic balance.
Dynamic Balance - Y-Balance Test Left Posterolateral Reach DistanceBaseline, Week 4, Week 8Change in dynamic balance measured by the normalized reach distance (%) of the left leg in the posterolateral direction on the Y-Balance Test. Reach distance is normalized to leg length. Longer reach distances indicate better dynamic balance.
Limb Asymmetry - Y-Balance Test Anterior Asymmetry IndexBaseline, Week 4, Week 8Change in inter-limb coordination measured by the anterior asymmetry index (%) on the Y-Balance Test. The index is calculated as the absolute difference between right and left anterior reach distances divided by the average of both legs. Lower asymmetry indicates better bilateral coordination.
Limb Asymmetry - Y-Balance Test Posteromedial Asymmetry IndexBaseline, Week 4, Week 8Change in inter-limb coordination measured by the posteromedial asymmetry index (%) on the Y-Balance Test. The index is calculated as the absolute difference between right and left posteromedial reach distances divided by the average of both legs. Lower asymmetry indicates better bilateral coordination.
Limb Asymmetry - Y-Balance Test Posterolateral Asymmetry IndexBaseline, Week 4, Week 8Change in inter-limb coordination measured by the posterolateral asymmetry index (%) on the Y-Balance Test. The index is calculated as the absolute difference between right and left posterolateral reach distances divided by the average of both legs. Lower asymmetry indicates better bilateral coordination.
Postural Stability - Biodex Overall Stability IndexBaseline, Week 4, Week 8Change in static postural stability measured by the Overall Stability Index from the Biodex Balance System. The index quantifies the variance of foot platform displacement in degrees. Lower scores indicate better stability.Unit of Measure: Degrees (°)
Dynamic Postural Control - Biodex Limits of Stability Completion TimeBaseline, Week 4, Week 8Change in dynamic postural control measured by the completion time (seconds) on the Limits of Stability test of the Biodex Balance System. Participants move their center of gravity to targets in 8 directions. Shorter completion times indicate better dynamic control.Unit of Measure:Seconds (s)
Dynamic Postural Control - Biodex Limits of Stability Directional ControlBaseline, Week 4, Week 8Change in dynamic postural control measured by the directional control score (%) on the Limits of Stability test of the Biodex Balance System. Higher percentages indicate more efficient movement of the center of gravity toward targets.Unit of Measure:Percentage (%)

Secondary

MeasureTime frameDescription
Anxiety SymptomsBaseline, Week 4 (mid-intervention), Week 8 (post-intervention)Change in anxiety symptoms assessed by the Generalized Anxiety Disorder 7-item scale (GAD-7). The GAD-7 is a self-report questionnaire measuring anxiety symptoms over the past two weeks. Total scores range from 0 to 21, with higher scores indicating greater anxiety severity.
Depressive SymptomsBaseline, Week 4 (mid-intervention), Week 8 (post-intervention)Change in depressive symptoms assessed by the Patient Health Questionnaire 9-item scale (PHQ-9). The PHQ-9 is a self-report questionnaire measuring depression symptoms over the past two weeks. Total scores range from 0 to 27, with higher scores indicating greater depression severity.
Self-Esteem LevelBaseline, Week 4 (mid-intervention), Week 8 (post-intervention)Change in self-esteem assessed by the Rosenberg Self-Esteem Scale (RSES). The RSES is a 10-item self-report scale measuring global self-worth. Scores range from 0 to 30, with higher scores indicating higher self-esteem.
Motor Coordination DifficultiesBaseline, Week 4 (mid-intervention), Week 8 (post-intervention)Change in motor coordination assessed by the Adult Developmental Coordination Disorder Questionnaire (DCDQ). The DCDQ is a self-report measure evaluating motor coordination difficulties in daily activities. Total scores range from 15 to 75, with higher scores indicating greater coordination problems.
ADHD-Specific Quality of LifeBaseline, Week 4 (mid-intervention), Week 8 (post-intervention)Change in quality of life assessed by the Adult ADHD Quality of Life measure (AAQoL-29). The AAQoL-29 is a 29-item self-report questionnaire measuring life productivity, psychological health, relationships, and life outlook. Total scores range from 29 to 145, with higher scores indicating better quality of life.
Prefrontal Cortex Activation (Exploratory)Baseline (pre-intervention), Week 8 (post-intervention)Change in prefrontal cortex hemodynamic response measured by functional near-infrared spectroscopy (fNIRS) during cognitive tasks (N-back and emotional Stroop). Outcomes include oxygenated hemoglobin (HbO) concentration changes in dorsolateral prefrontal cortex (DLPFC), orbitofrontal cortex (OFC), and frontopolar area (FPA).
AgeBaselineParticipant age at the time of enrollment. Age is recorded as a continuous variable for descriptive purposes and will be used as a covariate in analyses.Unit of Measure: Years
HeightBaselineParticipant height measured in centimeters (cm) using a standardized stadiometer. Unit of Measure:Centimeters (cm)
WeightBaselineParticipant weight measured in kilograms (kg) using a calibrated digital scale.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026